Expert Critique

As a provider who treats patients with diabetes, one of my roles is choosing which medication or type of insulin to prescribe. Although there has been an increase in insulin options available, the financial burden on patients is significantly rising.

One of the major challenges for doctors and advanced practitioners is trying to stay familiar with the numerous insurance companies, different plans within each, and changes in formulary (preferred medication) when prescribing. Choice of insulin for our patients is driven more and more by cost. As the author describes the historical context of insulin production, it is perplexing that costs are skyrocketing when this medication has existed for nearly a century. In the past 20 years, the cost of a 10 mL bottle of rapid-acting insulin analogue (Novolog or Humalog) has increased from approximately $25 in 1996 to more than $250 in 2016! (Business Insider, May 15, 2017) More disturbingly, the companies that produce these insulins (Novo Nordisk and Eli Lilly respectively) appear to follow a “shadow pricing” technique that increases the price of these similar products simultaneously, eliminating a competitive market. Despite widespread criticism from advocacy groups like the American Diabetes Association, politicians and even a patient-initiated class action lawsuit last fall, both companies raised the list price of their insulins by another 8% in 2017.

The uncertain future of U.S. healthcare, including proposed cuts to Medicaid funding, leaves many patients with anxiety surrounding the affordability of these life-saving medications. Such uncertainty could lead to more people choosing high deductible plans to ensure coverage, leaving them vulnerable to rising out-of-pocket costs that even discount cards offered by pharmaceuticals might not mitigate.

Fortunately, the ADA offers resources at MakeInsulinAffordable.org, which also contains a petition with nearly 250,000 signatures urging Congress to act. Given the current healthcare market, patients and providers must work together as advocates for everyone with diabetes.

Full Critique

I had just ordered my lunch and, as I reached into my pocket, realized I left my insulin pen at home. I believe most of us with type 1 diabetes have encountered a similar situation at some point in our lives. I was more than two hours away from my house and needed insulin immediately, so the local pharmacy seemed like the logical place to go. Since I had recently filled my insulin prescription the additional medication was not covered and the cost would be completely out of pocket. Much to my surprise, one single pen of insulin was more than $150. My goal is to provide information in an objective fashion regarding the latest research and news on insulin so that we as patients, and our physicians, are well-informed. Of course, healthcare laws are always changing, but it is important to understand recent trends in pricing and the overall history of insulin.

History of Insulin

In 1921, Canadian scientists Frederick Banting and Charles Best discovered insulin and then in 1923, with James Collip, they were the first to establish a patent for the process of isolating insulin. And, they sold the patent to the University of Toronto for just $1 each! The idea was to make this newly discovered, life-saving medication available to all patients who needed it. This transformed the outlook for those with type 1 diabetes.

Analog versus human insulin

More than 90 years later, there have been incredible advances in insulin and it is essential for not only type 1, but also type 2 diabetes. One major shift in clinical practice is the routine use of analog (insulin aspart Novolog), insulin lispro (Humalog), and insulin glargine injection (Lantus) instead of human insulin because of its suggested rapid onset of action and ability to better mimic the body's natural secretion of insulin. For type 1 diabetes, this can help control post-prandial spikes and has proven benefit for overall blood sugar control. However, there is limited evidence that analog insulin is superior to human insulin for type 2 diabetes, yet they are still solely prescribed in clinical practice. Additionally, analog insulin has been argued as one of many reasons for increased prices and expenditure. It has been shown that analogs are often seven to eight times more expensive than human insulins.

What about Generic Insulin?

When I purchased my insulin pen at the pharmacy why couldn't I opt for a cheaper generic version like so many other drugs? This has long been debated as another reason for the increased price because there are no generic insulin products. The main reason is that insulin is considered a biologic (containing living cells) and subject to more stringent approval standards. The FDA has, however, approved the use of insulin glargine injection (Basaglar), which is technically not a generic, but known as a biosimilar or "follow-on" medication to Lantus . The good news is reports show it to be 15% cheaper than Lantus and 21% cheaper than insulin detemir (Levemir). CVS health has even announced that it will remove Lantus from their list of 2017 formulary medications and replace it with Basaglar. However, while the intention to drive down cost through the use of a biosimilar may be beneficial, there are concerns that Basaglar may be less effective compared with a now non-formulary Lantus.

The Industry

In 2014 insulin was a greater than $24 billion dollar industry. Specifically, in 2015, "Medicare Part D -- the outpatient prescription drug benefit associated with the government insurance program for patients older than 65 years -- spent more than $4.3 billion for just one long-acting insulin analogue, glargine," only behind antiviral agents used to treat hepatitis C. In addition, Medicaid, which is partially sponsored by the state and federal government, spent 1.4 billion on glargine alone. Put in other terms, between 1991 and 2014, the amount of money Medicaid paid pharmacies per unit of insulin increased by between $6.86 and $15.38, depending on insulin type. And, as a result, the increased cost has significant financial ramifications for patients. A study in the Journal of the American Medical Association showed out-of-pocket costs of insulin for people with type 2 diabetes increased by 89% from 2000 to 2010. Here is a comparison of the high cost of different insulin types without insurance .

The lack of pharmaceutical competition may be another reason for high prices as there are only three main companies responsible for insulin production; Sanofi, Novo Nordisk and Eli Lilly. In fact, Novolog and Humalog, two rapid acting analog insulins, have been accused of identical price increases at similar times; leaving few cheaper options. Some have acted and earlier this year, diabetes patients filed a lawsuit against these companies in Massachusetts for systematically increasing the list prices of insulin in an alleged fraudulent-pricing scheme. In addition in November, 2016, the American Diabetes Association called on Congress to examine insulin costs across the entire supply chain.

As a diabetic it is important to be well informed about the rapidly growing insulin industry and how it may affect access to medications. It is further important to understand the covered and not covered costs of your health insurance plan so that you can plan for any unforeseen financial burdens. Other information or ways to be involved can be found through the Coalition for Affordable Insulin or the Diabetes Patient Advocacy Coalition.

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